BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1931657 · Received December 17, 2010

    Report

    Report Number
    2024168-2010-02794
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 24, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4) PATIENT SELECTION. (B)(6). THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). FACTORS THAT CAN CONTRIBUTE TO THE STENT NOT BEING FULLY APPOSED TO THE VESSEL WALL INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, INFLATION TECHNIQUE DURING USE OF THE PRODUCT, AN INTERACTION WITH THE PATIENT ANATOMY AND/OR PREVIOUSLY IMPLANTED STENTS, POST DILATATION TECHNIQUE, OR UNDERSIZING OF THE VESSEL. THE STENT DELIVERY SYSTEM (SDS) WAS NOT RETURNED FOR ANALYSIS WHICH MAY HAVE AIDED THE INVESTIGATION. THERE WAS NO NOTE OF ANY DAMAGE TO THE SDS OR STENT IMPLANT OBSERVED PRIOR TO THE PROCEDURE, WHICH MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTIES EXPERIENCED. HOWEVER, IT WAS REPORTED THE XIENCE V WAS IMPLANTED IN A PATIENT WHO PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION (AMI) AND CORONARY CLOTTING. IT SHOULD BE NOTED THE XIENCE V INSTRUCTIONS FOR USE (IFU) STATES: SAFETY AND EFFECTIVENESS OF THE XIENCE V STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH RECENT ACUTE MYOCARDIAL INFARCTION (AMI) OR EVIDENCE OF THROMBUS IN THE TARGET VESSEL. IT IS UNKNOWN HOW THE USE OF XIENCE V IN THIS PATIENT SELECTION MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. ANGINA AND THROMBOSIS ARE LISTED IN THE IFU AS KNOWN ADVERSE PATIENT EFFECTS WITH CORONARY STENTING. IT IS POSSIBLE THE ANGINA AND EKG/ECG CHANGES WERE SECONDARY EFFECTS OF THE THROMBOSIS WHICH REQUIRED ADDITIONAL TREATMENT. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY DEPLOYING THE STENT AND PATIENT EFFECTS COULD NOT BE DETERMINED. ALL STENT DELIVERY SYSTEMS (SDS) ARE CONFIRMED BY VARIOUS QUALITY CHECKS TO VERIFY VISUAL, FUNCTIONAL AND DIMENSIONAL SPECIFICATIONS, INCLUDING PROPER BALLOON DIMENSIONS, AND PROPER STENT PLACEMENT. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER INFLATION AND STENT DEPLOYMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ACUTE MYOCARDIAL INFARCT AND CORONARY CLOTTING AND WAS TREATED WITH AN INTERVENTIONAL PROCEDURE OF THE PRE-DILATATED LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH SUCTIONING OF THE CLOTTING AND A 2.5X18MM XIENCE V STENT. POST-DILATATION WAS PERFORMED USING A 3.25X15MM NON-ABBOTT BALLOON CATHETER INFLATED TO 22 ATMOSPHERE (ATM). IT WAS NOTED THAT INTEREGLIN WAS ORDERED, BUT WAS NOT GIVEN AND IT WAS QUESTIONABLE IF PLAVIX WAS USED. THE SAME EVENING POST PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN AND ST ELEVATION. INTRAVASCULAR ULTRASOUND (IVUS) REVEALED THE STENT WAS NOT FULLY APPOSED TO THE VESSEL AND THROMBOSIS WAS PRESENT. THE PATIENT WAS REVASCULARIZED WITH A 3.5X15MM NON-ABBOTT BALLOON INFLATED TO 18 ATM AND IVUS CONFIRMED THE STENT WAS FULLY APPOSED TO THE VESSEL. THE PATIENT WAS REPORTEDLY DOING FINE AND THERE WAS NO REPORTED PATIENT SEQUELA. THE PATIENT WAS SCHEDULED TO BE DISCHARGED THE FOLLOWING DAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES: 356 MG/DL AND 156 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0091041

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention